Monday, May 13, 2019

   Sources of Medical Device / Equipment Field Use / Quality History

   Ques (heavily redacted) :  I am a South African medical doctor. I have been tasked by the         
   radiology department of one of our hospitals to do a review of medical diagnostic ultrasound 
   systems, specifically if there are studies looking specifically at the quality of the procured equipment 
   from the start.  I came across one of your articles and thought you may have some insights... 

Ans:  I'm not sure what article you're referring to, and the full nature of the assignment with which you've been tasked.  But, it sounds like you are to set up a system to review the quality of ultrasound products the hospital is considering purchasing.  If so, here's some approaches / suggestions: 
1.  ECRI Institute:
     I haven't looked at them for many years, but they used to provide analysis like the U.S.'          
     Consumer Reports, but on medical products;
2.  The U.S. FDA:
     The FDA maintains a MAUDE (Manufacturer's and Users Device Experience) database,
     which lists products that have been voluntarily reported to have problems (adverse events) in
     the field that could or did cause serious injury or death.  It's not complete, but it can provide
     an idea of field / use issues facing families of products cleared / approved by the FDA.
     You have to get the product's regulation number, by searching the US Federal Register, 21 
     CFR 800-series, and use that number in the MAUDE database.  You can also  search it by 
     common name / description, or manufacturer.  
     New US and EU labeling requirements -- UDI, GUDID (a database), are new but should 
     ultimately provide similar data globally.
3.  Only purchase products from companies following a quality management system, US FDA 
     CGMPs, 21 CFR 820 for devices / equipment, or ISO 13485 / EU MDD / MDR for   
     CE-marked equipment in Europe.  These companies are periodically inspected as to 
     adherence to those respective QMS', which means the equipment meet applicable
     standards / requirements, and were built / documented to required QMS law.

Tuesday, March 26, 2019

ISO 11135:2014 and The QMS

A little more on my answer to the question posed after the EO sterilization webinar:
Ques:  I have a vendor ETO a load for me... what do i need to ensure that they let the load sit or air out between PQ runs?    ISO  11135 or FDA requirement?

Ans:  As mentioned early in the presentation, ISO 11135 presupposes the existence of a viable QMS / CGMP system, as well as adherence to the validation requirements of the standard to complete a successful validation.  Since ISO 11135 is an international standard, it specifically references ISO 13485 requirements under (page 11 of the standard) 4 Quality Management System, 4.1 Documentation, and 4.2 Management Responsibility, and 4.3 Product Realization, et al.   ISO 13485 requires, among others, that a company and its supply chain / vendors adhere to the requirements of 13485 for medical devices.  The US FDA recognizes ISO 11135 as a consensus standard, so for the US, the QSR 21 CFR 820, the CGMPs would be the device QMS in lieu of ISO 13485 (both requirements are very similar).  
So such adherence would assure that your question is addressed.  This can be reafirmed by a Quality Agreement or Contractual Requirement, verified by Certification / Audit, and or by other means. 
-- John E. Lincoln

Saturday, March 23, 2019

CRO and Client Disagreement

Here's my further response to the question from the Device Changes webinar of 03/20:
Ques:    What is a CRO's responsibility in educating the sponsor in whether or not the product is a medical device or not? Often times sponsors argue that their product is a cosmetic when it is more like a medical device.
Ans:   As I mentioned, I'm not qualified to directly answer this question.  It goes to the heart of how you as a CRO determine what potential clients you will accept as a formal client, and your legal department's and corporate policies.  As mentioned, as a consultant, I lay out the terms under which I will take on a client, and one of those is clarity of the definition of the project and its scope.  That includes agreement on applicable FDA requirements and definitions.  If the definition is subject to disagreement, then clarify what the proposal will address.
If the definition of cosmetic or device is not clear then define in your agreement just what your services cover, and the approach required by the FDA based on the definition chosen, and that the results are dependent on the chosen definition as it lays out the approaches taken.  This obviously has to be run through your legal department (as mentioned, I am not a lawyer and do not give legal advice). 
You have the right (and responsibility) to turn down clients that will not work with you, and certainly those who will not abide by FDA requirements.
Hope that helps.

Friday, February 22, 2019

Does the addition of new production equipment require a revalidation of the sterilization process?

To answer that question:  If the particulate count only increases, that will not affect the sterilization validation.  If the bioburden load increases then additional verification / testing will be required.  I doubt that the addition of another piece of equipment will increase bioburden, though it will increase particulate (and possibly oil vapor if any compressed air escapes into the controlled environment (should be plumbed out)).  If the equipment also requires additional human handling of the product, then there could be increased product bioburden.
After the implementation of the new equipment, If there is increased product bioburden, then at the very least a half cycle should be run on the product, and then test sterility of some product / PCDs in the most difficult to sterilize locations in the load at a half cycle.  Then either complete the cycle or do a full cycle on the load if that was a production run (with data to prove that additional sterilization runs do not negatively affect product function). 
Generally the addition of some additional equipment into a controlled environment does not create a serious challenge to the sterilization cycle.
Of course document all the above.  Could be an addendum to the last sterilization validation test report.